Generic Nextstellis Availability
Last updated on Apr 10, 2025.
Nextstellis is a brand name of drospirenone/estetrol, approved by the FDA in the following formulation(s):
NEXTSTELLIS (drospirenone; estetrol - tablet;oral)
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Manufacturer: MAYNE PHARMA
Approval date: April 15, 2021
Strength(s): 3MG;14.2MG [RLD]
Is there a generic version of Nextstellis available?
No. There is currently no therapeutically equivalent version of Nextstellis available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nextstellis. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Orodispersible dosage unit containing an estetrol component
Patent 11,793,760
Issued: October 24, 2023
Inventor(s): Jaspart; Séverine Francine Isabelle et al.
Assignee(s): ESTETRA SRL (Liège, BE)The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of: 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and 75-99.9 wt. % of one or more pharmaceutically acceptable ingredients; the solid dosage unit comprising at least 100 μg of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 μm to 50 μm. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.
Patent expiration dates:
- June 17, 2036✓
- June 17, 2036
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Orodispersible dosage unit containing an estetrol component
Patent 11,957,694
Issued: April 16, 2024
Inventor(s): Jaspart; Séverine Francine Isabelle et al.
Assignee(s): ESTETRA SRL (Liége, BE)An orodispersible solid pharmaceutical dosage unit of estetrol is disclosed. The solid dosage unit is easy to manufacture and suited for sublingual, buccal or sublabial administration. The orodispersible solid pharmaceutical dosage unit can include at least 100 μg of an estetrol component and pharmaceutically acceptable excipients. Methods of manufacturing the orodispersible solid pharmaceutical dosage unit are also disclosed.
Patent expiration dates:
- June 17, 2036✓
- June 17, 2036
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Orodispersible dosage unit containing an estetrol component
Patent 11,964,055
Issued: April 23, 2024
Inventor(s): Jaspart; Séverine Francine Isabelle et al.
Assignee(s): ESTETRA SRL (Liége, BE)The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of: 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and 75-99.9 wt. % of one or more pharmaceutically acceptable ingredients; the solid dosage unit comprising at least 100 μg of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 μm to 50 μm. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.
Patent expiration dates:
- June 17, 2036✓
- June 17, 2036
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Contraceptive methods with improved pearl index
Patent 12,233,074
Issued: February 25, 2025
Inventor(s): Foidart; Jean-Michel et al.
Assignee(s): ESTETRA SRL (Liège, BE)Described are methods of providing contraception in a woman having a BMI≥30.0 kg/m.sup.2, comprising: selecting a woman determined to have a BMI≥30.0 kg/m.sup.2, and then orally administering to the selected woman a therapeutically effective amount of an estetrol component at a daily dose of from 14 mg to 16 mg, based on the estetrol moiety, and drospirenone at a daily dose of from 2.5 mg to 3.5 mg. Also described are methods of contraception that achieves a Pearl Index of <5 in women having a BMI≥30.0 kg/m.sup.2, comprising: selecting a woman determined to have a BMI≥30.0 kg/m.sup.2, and then orally administering to the selected woman a therapeutically effective amount of an estetrol component at a daily dose of from 14 mg to 16 mg, based on the estetrol moiety, and drospirenone at a daily dose of from 2.5 mg to 3.5 mg, wherein the method comprises daily administration of the estetrol component and drospirenone on 24 consecutive days followed by a hormone-free period of 4 consecutive days.
Patent expiration dates:
- February 9, 2043✓✓
- February 9, 2043
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Drug delivery system comprising a tetrahydroxilated estrogen for use in hormonal contraception
Patent 7,732,430
Issued: June 8, 2010
Inventor(s): Bunschoten; Evert Johannes et al.
Assignee(s): Pantarhei Bioscience B.V. (Zeist, NL)A method of contraception in mammalian females, which method comprises the oral administration of an estrogenic component and a progestogenic component to a female of childbearing capability in an amount effective to inhibit ovulation, wherein the estrogenic component is selected from the group consisting of substances represented by the following formula (1) ##STR00001## in which R.sub.1, R.sub.2, R.sub.3, R.sub.4 independently are a hydrogen atom, a hydroxyl group or an alkoxy group with 1-5 carbon atoms; each of R.sub.5, R.sub.6, R.sub.7 is a hydroxyl group; and no more than 3 of R.sub.1, R.sub.2, R.sub.3, R.sub.4 are hydrogen atoms; precursors capable of liberating a substance according to the aforementioned formula when used in the present method; and mixtures of one or more of the aforementioned substances and/or precursors. Another aspect of the invention concerns a pharmaceutical kit comprising oral dosage units that contain the aforementioned estrogenic component and/or a progestogenic component.
Patent expiration dates:
- March 2, 2026✓✓
- March 2, 2026
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- April 15, 2026 - NEW CHEMICAL ENTITY
More about Nextstellis (drospirenone / estetrol)
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- Drug class: contraceptives
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
